AVEO Reports Third Quarter 2017 Financial Results and Provides Business Update
“The third quarter was a transformative period for
Mr. Bailey continued, “In addition, we expect the imminent launch of
tivozanib (FOTIVDA®) in
Tivozanib (FOTIVDA®) Approved in the
European Union for the Treatment of Advanced Renal Cell Carcinoma(RCC). In August 2017, AVEOannounced that the European Commission(EC) approved tivozanib (FOTIVDA®) for the treatment of adult patients with RCC in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Successfully Passed the
TIVO-3 Futility Analysis with No Changes to Study Protocol. In October 2017, AVEOannounced the completion of a pre-planned interim futility analysis of the Phase 3 TIVO-3 trial, the Company’s randomized, controlled, multi-center, open-label study to compare tivozanib (FOTIVDA®) to sorafenib (NEXAVAR®) in subjects with advanced RCC. Based on the results of the futility analysis, which were reviewed by an independent statistician, the study continued as planned without modification. The analysis did not allow for early stopping due to efficacy to assure adequate follow-up for the key secondary endpoint of overall survival. The Company continues to expect the TIVO-3 trial to read out in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a potential regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.
Phase 1 Results from the TiNivo Trial of Tivozanib and Nivolumab
(OPDIVO®) in RCC - Oral Presentation at the 16th
International Kidney Cancer Symposium. On
November 3, 2017 AVEOpresented results from the Phase 1 portion of the Phase 1/2 TiNivo study at the 16th International Kidney Cancer Symposium. The oral presentation, titled “TiNivo: A Phase 1b Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma,” was given by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study. The TiNivo trial is a Phase 1/2 multicenter trial of tivozanib (FOTIVDA®) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO®), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma. The ongoing Phase 1 portion of the trial enrolled six patients, and demonstrated that the combination of tivozanib and nivolumab was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The results also demonstrated promising early signs of potential efficacy, with 67% of patients demonstrating a partial response (PR), and a 100% disease control rate (PR + stable disease). Five out of six patients remain on study therapy. Enrollment of approximately 20 patients in the Phase 2 portion is ongoing. The trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.
TiNivo Combination Study Opt-in. In
September 2017, AVEOannounced that EUSA Pharma, under its multi-territory licensing agreement with AVEO for tivozanib (FOTIVDA®), opted in to co-develop the Phase 1/2 TiNivo study and potential future combination studies in exchange for a research and development reimbursement payment totaling $2.0 million. Under terms of the agreement, EUSA will fund up to half of the Phase 1/2 TiNivo study, not to exceed $2.0 million, and may utilize data from study for regulatory or commercial purposes.
Receipt of Payments from EUSA Pharma and CANbridge. In
September 2017, AVEOannounced the receipt of a $4.0 million research and development reimbursement payment from EUSA Pharma related to the approval of tivozanib (FOTIVDA®) for the treatment of adult patients with advanced RCC in Europe, and a $0.5 million milestone payment from CANbridge related to manufacturing development activities for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.
Third Quarter 2017 Financial Highlights
AVEOended Q3 2017 with $37.4 millionin cash, cash equivalents and marketable securities as compared with $23.3 millionat December 31, 2016.
Total collaboration revenue was approximately
$4.6 millionin Q3 2017 compared with $1.0 millionfor Q3 2016.
Research and development expense was
$4.7 millionin Q3 2017 compared with $4.4 millionfor Q3 2016.
General and administrative expense was
$2.1 millionin Q3 2017 compared with $2.1 millionfor Q3 2016.
Net loss for Q3 2017 was
$26.4 million, or a loss of $0.22per basic and diluted share, compared with a net loss of $5.0 million, or a loss of $0.07per basic and diluted share for Q3 2016. Approximately $23.5 million of the net loss was a non-cash loss attributable to the increase in the fair value of the warrant liability that was recorded in Q3 2017 that principally resulted from the increase in the stock price that occurred within the quarter. In Q3 2016, the non-cash gain attributable to fair value of the warrant liability was $1.2 million.
Updated Financial Guidance
We believe that our $37.4 million in cash resources would allow us to fund our planned operations into the fourth quarter of 2018. This estimate assumes no receipt of additional milestone or royalty payments from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity financings, no debt financings and no further sales of equity under our Sales Agreement with FBR or through the exercise of our outstanding PIPE Warrants. This estimate also assumes no acceleration in repayment of the term loan by Hercules in the event of non-compliance with the $10.0 million financial covenant.
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|AVEO PHARMACEUTICALS, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration and licensing revenue||$||4,614||$||992||$||7,497||$||2,388|
|Research and development||4,666||4,444||19,503||16,020|
|General and administrative||2,101||2,141||6,734||6,344|
|Loss from operations||(2,153||)||(5,593||)||(18,740||)||(19,976||)|
|Other expense, net:|
|Interest expense, net||(655||)||(551||)||(1,736||)||(1,388||)|
|Change in fair value of warrant liability||(23,538||)||1,178||(47,947||)||182|
|Other expense, net||(24,193||)||627||(49,683||)||(1,206||)|
|Loss before provision for income taxes||(26,346||)||(4,966||)||(68,423||)||(21,182||)|
|Provision for income taxes||(51||)||—||(101||)||(100||)|
|Net loss per share — basic and diluted||$||(0.22||)||$||(0.07||)||$||(0.67||)||$||(0.32||)|
|Weighted average number of common shares outstanding||118,006||75,861||101,754||67,046|
|Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||37,409||$||23,348|
|Prepaid expenses and other current assets||1,744||1,940|
|Liabilities and stockholders’ deficit|
|Accounts payable and accrued expenses||$||11,058||$||7,715|
|Deferred revenue and research and development reimbursements||3,190||2,207|
|Total liabilities and stockholders’ deficit||$||41,711||$||27,285|
Source: AVEO Oncology
David Pitts, 212-600-1902